IMPORTANT SAFETY INFORMATION for QTERN®(dapagliflozin and saxagliptin)

Who should not take QTERN?

Do not take QTERN if you:

are allergic to dapagliflozin, saxagliptin or any of the ingredients in QTERN. Symptoms of a serious allergic reaction to QTERN may include: swelling of the face, lips, tongue and throat that may cause difficulty in breathing or swallowing; difficulty with swallowing or breathing; skin rash, itching, flaking or peeling; raised red patches on your skin (hives). If you have any of these symptoms, stop taking QTERN and call your health care provider or go to the hospital emergency room right away

have severe kidney problems or are on dialysis. Your health care provider should do blood tests to check how well your kidneys are working before and during your treatment with QTERN

What are the possible side effects of QTERN?

QTERN may cause serious side effects including:

Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking QTERN, tell your health care provider if you ever had pancreatitis, gallstones, history of alcoholism or high triglyceride levels. Stop taking QTERN and contact your health care provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis

Heart Failure. Before taking QTERN tell your health care provider if you have ever had heart failure or problems with your kidneys. Contact your health care provider right away if you have any of the following symptoms of heart failure: increasing shortness of breath or trouble breathing, especially when you lie down; swelling or fluid retention in the feet, ankles or legs; an unusually fast increase in weight; unusual tiredness

Dehydration (the loss of body water and salt) which may cause you to feel dizzy, faint, lightheaded or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure, including water pills (diuretics), are 65 years of age or older, are on a low salt diet or have kidney problems

Ketoacidosis occurred in people with type 1 and type 2 diabetes during treatment with dapagliflozin, one of the medicines in QTERN. Ketoacidosis is a serious condition which may require hospitalization and may lead to death. Symptoms may include nausea, tiredness, vomiting, trouble breathing, and abdominal pain. If you get any of these symptoms, stop taking QTERN and call your health care provider right away. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL

Kidney problems. Sudden kidney injury occurred in people taking dapagliflozin, one of the medicines in QTERN. Talk to your health care provider right away if you reduce the amount you eat or drink, or if you lose liquids; for example, from vomiting, diarrhea, or excessive heat exposure

Serious urinary tract infections (UTI), some that lead to hospitalization, occurred in people taking dapagliflozin, one of the medicines in QTERN. Tell your health care provider if you have any signs or symptoms of UTI including a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine with or without fever, back pain, nausea, or vomiting

Low blood sugar (hypoglycemia). If you take QTERN with another medicine that can cause low blood sugar such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. Symptoms of low blood sugar include shaking, sweating, rapid heartbeat, change in vision, hunger, headache or change in mood. Follow your health care provider’s instructions for treating low blood sugar

Vaginal yeast infections in women who take QTERN. Talk to your health care provider if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese) or vaginal itching

Yeast infection of skin around the penis (balanitis) in men who take QTERN. Talk to your health care provider if you experience redness, itching, or swelling of the penis; rash of the penis; foul smelling discharge from the penis; or pain in the skin around penis. Certain uncircumcised men may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis

Bladder cancer. In studies of dapagliflozin, one of the medicines in QTERN, bladder cancer occurred in a few more people who were taking dapagliflozin than in people who were taking other diabetes medications. There were too few cases of bladder cancer to know if bladder cancer was related to dapagliflozin. You should not take QTERN if you have bladder cancer. Tell your health care provider right away if you have blood or a red color in your urine or pain while you urinate

Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in QTERN, may develop joint pain that can be severe. Call your health care provider if you have severe joint pain

Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in QTERN, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your health care provider right away if you develop blisters or the breakdown of the outer layer of your skin

The most common side effects of QTERN include upper respiratory tract infection, urinary tract infection, and dyslipidemia (abnormal amounts of fats in the blood).

What should I tell my health care provider before taking QTERN?

Before you take QTERN, tell your health care provider:

all of your medical conditions, including problems with your kidneys, liver, bladder, or pancreas

if you have had, or have risk factors for, ketoacidosis (including type 1 diabetes, are eating less due to illness, surgery, or a change in your diet, are going to have surgery, or binge drink)

if you are pregnant, or plan to become pregnant.QTERN may harm your unborn baby

if you are breastfeeding or plan to breastfeed. It is unknown if QTERN passes into your breastmilk

about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

APPROVED USES

What is QTERN?

QTERN is a prescription medicine that contains dapagliflozin and saxagliptin. QTERN is used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes

QTERN is not for people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in your blood or urine).

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